Opportunity Information: Apply for PAR 13 309
Apply for PAR 13 309
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Aug 5, 2013 and posted on Aug 5, 2013.
- Applicants must submit their applications by Aug 16, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: County governments Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Public and State controlled institutions of higher education State governments Public housing authorities/Indian housing authorities Small businesses Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments City or township governments For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The NIH funding opportunity titled "Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R01)" (Funding Opportunity Number PAR-13-309) supports research projects that move practical discoveries toward real-world improvements in medication use for two groups that are often underrepresented in drug development and safety studies: children across different developmental stages and pregnant women (including impacts on the developing fetus). The central focus is translational and clinical research, including clinical trials, that can explain how drugs work, why patients respond differently, and what drives safety risks in these populations. In plain terms, the FOA is aimed at generating evidence that helps clinicians and researchers use medicines more safely and effectively in pediatric and obstetric care, while also encouraging the development of new therapies or safer, more tailored ways to use existing drugs when current options do not meet clinical needs.
A key theme of the announcement is understanding mechanisms of drug action, response, and toxicity. For pediatric patients, the FOA recognizes that drug absorption, distribution, metabolism, and elimination can change dramatically from infancy through adolescence, and that these developmental differences can affect dosing, effectiveness, and side effects. For pregnancy, the FOA highlights the complexities introduced by maternal physiologic changes and placental biology, as well as the need to understand fetal exposure and developmental consequences. Projects supported under this opportunity are expected to go beyond simply observing outcomes; they should help explain underlying biological and pharmacologic mechanisms and translate those insights into better dosing strategies, improved safety monitoring, optimized therapeutic regimens, or new approaches to drug development relevant to these populations.
This opportunity uses the NIH R01 grant mechanism, meaning it is intended for discrete, hypothesis-driven research projects with clearly defined aims, methods, and measurable outcomes. The funding instrument type is a grant, and the activity area is categorized under Health, consistent with the CFDA listing 93.865 (Child Health and Human Development Extramural Research). Importantly, there is no cost sharing or matching requirement, which means applicants are not required to contribute non-federal funds as a condition of the award.
Eligibility is broad and includes many types of organizations that can conduct biomedical research. Eligible applicants include public and private institutions of higher education, state and local governments (including county, city/township, special district governments), independent school districts, federally recognized tribal governments and other tribal organizations, public housing authorities/Indian housing authorities, nonprofits (both 501(c)(3) and non-501(c)(3)), and for-profit organizations (including small businesses and other for-profits). The FOA explicitly includes a range of institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs). Federal agencies and faith-based or community-based organizations are also included where applicable. International participation is permitted: non-U.S. (foreign) organizations and foreign institutions may apply, non-U.S. components of U.S. organizations are eligible, and foreign components (as defined by NIH policy) are allowed.
From an administrative timeline perspective, the FOA was posted and created on August 5, 2013, with an original and final closing date of August 16, 2016, and it was archived on September 16, 2016. That means the specific announcement is no longer accepting applications under that exact posting, but it remains a useful reference for understanding NIH priorities in pediatric and obstetric pharmacology and for tracking related or successor NIH opportunities.
The sponsoring agency is the National Institutes of Health. The full announcement was made available through the NIH Grants Guide (link provided in the source data). For access or technical issues, the FOA lists the NIH Office of Extramural Research (OER) Webmaster as the point of contact for troubleshooting access and linking problems.
FAQs: Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R01) (PAR-13-309)
What is the title and funding opportunity number of this NIH grant?
The opportunity is titled "Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R01)" and the Funding Opportunity Number is PAR-13-309.
What is the main purpose of this funding opportunity?
This NIH opportunity supports translational and clinical research (including clinical trials) that moves practical discoveries toward real-world improvements in medication use for children across developmental stages and for pregnant women, including impacts on the developing fetus.
Which patient populations are the focus of this FOA?
The FOA focuses on two populations that are often underrepresented in drug development and safety studies: pediatric patients (from infancy through adolescence) and pregnant women (including considerations related to fetal exposure and development).
What kinds of research does the FOA emphasize?
The central emphasis is translational and clinical research designed to explain how drugs work, why patients respond differently, and what drives safety risks in pediatric and obstetric settings. The FOA highlights work that goes beyond observing outcomes by examining underlying biological and pharmacologic mechanisms.
Are clinical trials allowed under this opportunity?
Yes. The FOA explicitly includes translational and clinical research, including clinical trials.
What does the FOA mean by "translational" in this context?
In this context, translational research means generating evidence and mechanistic understanding that can be applied to improve clinical medication use, such as better dosing strategies, improved safety monitoring, optimized therapeutic regimens, or new approaches to drug development for pediatric and obstetric care.
What is the key scientific theme highlighted in the announcement?
A central theme is understanding mechanisms of drug action, response, and toxicity, with the goal of translating those insights into safer and more effective medication use in children and during pregnancy.
Why is pediatric pharmacology specifically called out as complex?
The FOA recognizes that drug absorption, distribution, metabolism, and elimination can change dramatically from infancy through adolescence, which can affect dosing, effectiveness, and side effects.
Why is pharmacology in pregnancy specifically called out as complex?
The FOA highlights that pregnancy involves maternal physiologic changes and placental biology complexities, and it emphasizes understanding fetal exposure and potential developmental consequences.
Does the FOA support studies that only observe clinical outcomes?
The FOA states that supported projects are expected to go beyond simply observing outcomes. Projects should help explain underlying biological and pharmacologic mechanisms and translate those insights into practical improvements.
What types of deliverables or practical improvements does the FOA aim to generate?
The FOA describes outcomes such as improved dosing strategies, improved safety monitoring, optimized therapeutic regimens, and new approaches to drug development relevant to pediatric and obstetric populations, especially when current options do not meet clinical needs.
What grant mechanism is used for this opportunity?
This opportunity uses the NIH R01 grant mechanism.
What does it mean that this is an R01 opportunity?
It means the FOA is intended for discrete, hypothesis-driven research projects with clearly defined aims, methods, and measurable outcomes.
What is the funding instrument type and activity area?
The funding instrument type is a grant. The activity area is categorized under Health, consistent with CFDA 93.865 (Child Health and Human Development Extramural Research).
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement, so applicants are not required to contribute non-federal funds as a condition of the award.
Who is eligible to apply?
Eligibility is broad and includes many organization types, such as public and private institutions of higher education; state and local governments (including county, city/township, and special district governments); independent school districts; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits (501(c)(3) and non-501(c)(3)); and for-profit organizations (including small businesses and other for-profits). Federal agencies and faith-based or community-based organizations are also included where applicable.
Are minority-serving institutions explicitly included?
Yes. The FOA explicitly includes institution types such as HBCUs, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs).
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized tribal governments and other tribal organizations are listed as eligible applicants.
Are for-profit organizations eligible?
Yes. For-profit organizations, including small businesses and other for-profits, are included as eligible applicants.
Can non-U.S. (foreign) organizations apply?
Yes. International participation is permitted. Non-U.S. (foreign) organizations and foreign institutions may apply, non-U.S. components of U.S. organizations are eligible, and foreign components (as defined by NIH policy) are allowed.
What are the posted and closing dates for PAR-13-309?
The FOA was posted and created on August 5, 2013. The original and final closing date was August 16, 2016, and it was archived on September 16, 2016.
Is this specific FOA still accepting applications?
No. The FOA is archived and the final closing date has passed, so the specific announcement PAR-13-309 is no longer accepting applications under that exact posting.
Why might this archived FOA still be useful?
The archived announcement can still be a useful reference for understanding NIH priorities in pediatric and obstetric pharmacology and therapeutics and for tracking related or successor NIH opportunities.
Who is the sponsoring agency?
The sponsoring agency is the National Institutes of Health (NIH).
Where was the full announcement made available?
The full announcement was made available through the NIH Grants Guide (as referenced in the source information).
Who is listed for access or technical issues with the announcement?
For access or technical issues, the FOA lists the NIH Office of Extramural Research (OER) Webmaster as the point of contact for troubleshooting access and linking problems.
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Applicants also applied for:
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| Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R03) Apply for PAR 13 310 Funding Number: PAR 13 310 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $50,000 |
| Translational Research in Pediatric and Obstetric Pharmacology and Therapeutics (R21) Apply for PAR 13 311 Funding Number: PAR 13 311 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
| Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R01) Apply for PAR 13 325 Funding Number: PAR 13 325 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Development of Appropriate Pediatric Formulations and Pediatric Drug Delivery Systems (R21) Apply for PAR 13 326 Funding Number: PAR 13 326 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
| Development of Appropriate Pediatric Formulations and Drug Delivery Systems (R03) Apply for PAR 13 344 Funding Number: PAR 13 344 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $50,000 |
| Development of Appropriate Pediatric Formulations and Drug Delivery Systems (R43) Apply for PAR 13 345 Funding Number: PAR 13 345 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $150,000 |
| Development of Appropriate Pediatric Formulations and Drug Delivery Systems STTR (R41) Apply for PAR 13 346 Funding Number: PAR 13 346 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
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| Enhancing the Capacity for Biomedical Research on Tuberculosis for HIV infected Mothers and Children in India (R01) Apply for RFA HD 14 025 Funding Number: RFA HD 14 025 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $350,000 |
| Developmental Origins of Health and Disease (DOHaD) Epigenetic Modification in Gametogenesis and Transgenerational Inheritance (R01) Apply for PAR 13 385 Funding Number: PAR 13 385 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $250,000 |
| Female Contraceptive Development Program (U01) Apply for RFA HD 14 024 Funding Number: RFA HD 14 024 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $250,000 |
| Discovery of Molecular Targets for Pregnancy Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (SBIR) (R43/R44) Apply for RFA HD 14 031 Funding Number: RFA HD 14 031 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Discovery of Molecular Targets for Pregnancy Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (R01) Apply for PAR 13 389 Funding Number: PAR 13 389 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Discovery of Molecular Targets for Pregnancy Related/Induced Diseases and Development of Therapeutics to Prevent/Treat These Diseases (STTR) (R41/R42) Apply for RFA HD 14 032 Funding Number: RFA HD 14 032 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
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| Juvenile Protective Factors and Their Effects on Aging (R03) Apply for PAR 14 022 Funding Number: PAR 14 022 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $200,000 |
| U.S South Africa Program for Collaborative Biomedical Research (U01) Apply for RFA AI 14 018 Funding Number: RFA AI 14 018 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $225,000 |
| Data Sharing for Demographic Research Infrastructure Program (U24) Apply for RFA HD 14 015 Funding Number: RFA HD 14 015 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: Case Dependent |
| Intellectual and Developmental Disabilities Research Centers 2014 (U54) Apply for RFA HD 14 012 Funding Number: RFA HD 14 012 Agency: National Institutes of Health Category: Health Income Security and Social Services Funding Amount: $1,300,000 |
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